The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.

Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:

Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls [ Time Frame: End of surgery and 12 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls [ Time Frame: End of surgery and 12 hours postoperatively ] [ Designated as safety issue: No ]

Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.

Other Name: corlopam

Active Comparator: Fenoldopam

Drug infusion

Drug: Placebo

Saline continuous infusion during cardiopulmonary by pass at 1 ml/h

Other Name: saline

Drug: Fenoldopam

Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.

Other Name: corlopam

Eligibility

Ages Eligible for Study:

up to 365 Days

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00982527